A Multicenter Study to Evaluate the Efficacy and Safety of Cinryze® for the Treatment of Acute Antibody-mediated Rejection in Participants With Kidney Transplant

Phase 3 Terminated 39 enrolled Shire

RandomizedParallel-groupTriple-blindTreatment

Summary

The main purpose of the study is to evaluate the efficacy of CINRYZE administered with plasmapheresis, plasma exchange, or immune adsorption treatments and sucrose-free immunoglobulin (IVIg) for the treatment of acute antibody-mediated rejection (AMR) of renal allograft in kidney transplant recipients as measured by the proportion of participants with new or worsening transplant glomerulopathy (TG) at 6 months after treatment initiation.

Timeline

Start: 2016-05-20
Primary completion: 2019-05-31
Completion: 2019-05-31

Outcome

Missed primary endpoint

Stopped: “Following a pre-scheduled interim analysis performed by the DMC, it was determined that the study met the pre-specified criteria for futility.”

registry analysis (superiority test); Placebo vs CINRYZE; p = 0.6857; Difference in percentage 2.6 (95% CI -29.4 to 34.5); Fisher Exact NCT02547220 ↗

Publications

Karpman D, Bekassy Z, Grunenwald A, Roumenina LT. A role for complement blockade in kidney transplantation. Cell Mol Immunol. 2022 Jul;19(7):755-757. doi: 10.1038/s41423-022-00854-5. Epub 2022 Mar 24. No abstract available.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	CINRYZE	Protein / enzyme biologic	2500 iu	—